FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1013999
·
Received March 13, 2008
Report
- Report Number
- 3015876-2008-00174
- Event Type
- Malfunction
- Date Received
- March 13, 2008
- Date of Event
- February 14, 2008
- Report Date
- February 14, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER DECLINED AN OFFER OF SERVICE FROM PHYSIO-CONTROL. PHYSIO RECOMMENDED REPLACING THE POWER CONVERSION PCB ASSEMBLY AND PROVIDED PART NUMBER TO ORDER REPLACEMENT.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE WILL NOT TURN OFF WITHOUT DISCONNECTING THE AC CORD AND BATTERY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 9 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC. | 9 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |